Povidone Iodine
Solution · Topical, Oral
Active ingredient
Active ingredient Povidone Iodine 10% (equivalent to 1% available iodine)
Purpose
Purpose Antiseptic
Uses
Uses healthcare antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent infection in minor cuts, scrapes and burns single use when used for patient preoperative skin preparation
Warnings
Warnings For external use only. Do not use in the eyes longer than 1 week unless directed by a doctor on individuals who are allergic or sensitive to iodine or apply over large areas of the body Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do not use
Do not use in the eyes longer than 1 week unless directed by a doctor on individuals who are allergic or sensitive to iodine or apply over large areas of the body
Stop use and ask a doctor
Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or serious burns
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions Clean the affected area. For preparation of the skin prior to surgery: apply product to the operative site prior to surgery For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Other information
Other information protect from freezing, avoid excessive heat
Inactive ingredients
Inactive ingredients citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
Label text from the FDA structured product label by Medline Industries, LP (revised Aug 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Povidone-iodine in 33 products
Povidone Iodine NDC products (33)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0924-5408 | Povidone-iodine 10 mg/mL Solution | Acme United Corporation | OTC MONOGRAPH DRUG |
| 24385-053 | Povidone-iodine .1 g/mL Solution | Amerisource Bergen | OTC MONOGRAPH DRUG |
| 70000-0757 | Povidone-iodine 100 mg/mL Solution | CARDINAL HEALTH 110, LLC. DBA LEADER | OTC MONOGRAPH DRUG |
| 81584-1102 | Povidone-iodine 100 mg/g Ointment | Dr Radows | OTC MONOGRAPH DRUG |
| 37808-624 | Povidone-iodine 10 mg/mL Solution | H E B | OTC MONOGRAPH DRUG |
| 50332-0056 | Povidone-iodine 10 mg/mL Solution | HART Health | OTC MONOGRAPH DRUG |
| 0395-9128 | Povidone-iodine 5 mg/mL Liquid | Humco Holding Group, Inc. | OTC MONOGRAPH DRUG |
| 0395-9123 | Povidone-iodine 100 mg/mL Liquid | Humco Holding Group, Inc. | OTC MONOGRAPH DRUG |
| 0395-9136 | Povidone-iodine 5 mg/mL Liquid | Humco Holding Group, Inc. | OTC MONOGRAPH DRUG |
| 0395-9129 | Povidone-iodine 50 mg/mL Liquid | Humco Holding Group, Inc. | OTC MONOGRAPH DRUG |
| 46414-7777 | Povidone-iodine 10 mg/mL Solution | James Alexander Corporation | OTC MONOGRAPH DRUG |
| 34645-1029 | Povidone-iodine .1 mg/mL Swab | Jianerkang Medical Co., Ltd | OTC MONOGRAPH DRUG |
| 34645-1043 | Povidone-iodine .1 mg/mL Swab | Jianerkang Medical Co., Ltd | OTC MONOGRAPH DRUG |
| 34645-4009 | Povidone-iodine 7.5 mg/mL Solution | Jianerkang Medical Co., Ltd | OTC MONOGRAPH DRUG |
| 34645-4059 | Povidone-iodine 10 mg/mL Solution | Jianerkang Medical Co., Ltd | OTC MONOGRAPH DRUG |
| 34645-4188 | Povidone-iodine 10 mg/mL Solution | Jianerkang Medical Co., Ltd | OTC MONOGRAPH DRUG |
| 0904-7639 | Povidone-iodine 100 mg/mL Solution | Major Pharmaceuticals | OTC MONOGRAPH DRUG |
| 0904-1103 | Povidone-iodine 100 mg/mL Solution | Major Pharmaceuticals | OTC MONOGRAPH DRUG |
| 81280-003 | Povidone-iodine .1 mg/mL Swab | Mazza Healthcare, LLC | OTC MONOGRAPH DRUG |
| 81280-002 | Povidone-iodine .1 mg/mL Swab | Mazza Healthcare, LLC | OTC MONOGRAPH DRUG |
| 53329-938 | Povidone-iodine .75 g/100mL Solution | Medline Industries, LP | OTC MONOGRAPH DRUG |
| 53329-946 | Povidone-iodine 10 mg/mL Swab | Medline Industries, LP | OTC MONOGRAPH DRUG |
| 53329-945 | Povidone-iodine 10 mg/mL Swab | Medline Industries, LP | OTC MONOGRAPH DRUG |
| 53329-941 | Povidone-iodine 10 mg/mL Cloth | Medline Industries, LP | OTC MONOGRAPH DRUG |
| 53329-939 | Povidone-iodine 10 mg/mL Solution | Medline Industries, LP | OTC MONOGRAPH DRUG |
| 82645-907 | Povidone-iodine 100 mg/mL Liquid | Pharma Nobis, LLC | OTC MONOGRAPH DRUG |
| 82645-908 | Povidone-iodine 5 mg/mL Liquid | Pharma Nobis, LLC | OTC MONOGRAPH DRUG |
| 68786-130 | Povidone-iodine .1 g/1 Swab | Sion Biotext Medical Ltd | OTC MONOGRAPH DRUG |
| 68786-140 | Povidone-iodine .1 g/1 Swab | Sion Biotext Medical Ltd | OTC MONOGRAPH DRUG |
| 69396-112 | Povidone-iodine 100 mg/g Ointment | Trifecta Pharmaceuticals USA LLC | OTC MONOGRAPH DRUG |
| 55681-751 | Povidone-iodine .1 g/g Swab | TwinMed LLC | OTC MONOGRAPH DRUG |
| 55681-752 | Povidone-iodine .1 g/1 Swab | TwinMed LLC | OTC MONOGRAPH DRUG |
| 55681-753 | Povidone-iodine .1 g/1 Swab | TwinMed LLC | OTC MONOGRAPH DRUG |
Povidone Iodine recalls
- D-0674-2025 Oct 1, 2025 · Class III · Ongoing
Subpotent drug - D-0546-2018 Mar 7, 2018 · Class II · Terminated
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Frequently asked questions
What is Povidone Iodine used for?
Uses healthcare antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent infection in minor cuts, scrapes and burns single use when used for patient preoperative skin preparation
Who makes Povidone Iodine?
Povidone Iodine is listed by 16 labelers in the FDA NDC directory, including Acme United Corporation, Amerisource Bergen, CARDINAL HEALTH 110, LLC. DBA LEADER, Dr Radows.
Has Povidone Iodine been recalled?
The FDA enforcement database lists 2 recalls for Povidone Iodine, most recently D-0674-2025 (class iii): Subpotent drug